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Androxal (enclomiphene citrate)

Jolene Berg, MD

The study will determine the effects of three doses of Androxal(enclomiphene citrate)on morning testosterone versus AndroGel(approved topical treatment)in men with low testosterone (\<350 ng/dL)after 6 weeks of continuous dosing.

Study will require 7 visits, which includes 2 overnight stays in a clinic. One visit is an eye exam. Blood samples are required at all visits including sampling every hour for a 24 hour time period during the 2 overnight stays. A six month extension study will be available for all subjects completing the 6-week study.

The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone)

A Randomized, Single Blind, Multi-Center Phase II Study to Evaluate the Effect of Three Different Doses of Androxal and AndroGel on 24-Hour Luteinizing Hormone and Testosterone in Normal Healthy Men

The area under the curve for plasma concentration over time from zero to 24 hours (AUC0-24).

The primary efficacy endpoint will be 24-hour average (TTavg) and maximum (TTmax) testosterone concentration compared to baseline after 6 weeks of treatment.

Time points (in hours after dosing) at which testosterone concentration was measured are: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24.

Changes in morning LH after continuous dosing

Changes in morning FSH after continuous dosing

Repros Therapeutics Inc.

enclomiphene citrate: capsule oral

1X a day 6 weeks

Androxal 6.25 mg

Androxal 12.5 mg

Androxal 25 mg

AndroGel 5G topical testosterone

Testosterone: topical gel

1X a day 6 weeks

AndroGel

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

The baseline analysis consisted of all subjects enrolled.

Jennifer L. Wike

Regression of 24 Hours Average Total Testosterone, Treatment Group and Morning Testosterone at Week 6.

Modeling 24 hour average total testosterone by morning testosterone and treatment group.

TTavg at Baseline

TTavg at Week 6

TTmax at Baseline

TTmax at Week 6

ITT, subjects who received at least one dose of study drug and had at least one post-dose efficacy measure.

24 Hour Average and Maximum Testosterone Concentration

ANOVA results - change from baseline in morning LH at Week 2. Modeling change from baseline by treatment group.

ANOVA results - change from baseline in morning LH at Week 4. Modeling change from baseline by treatment group.

ANOVA results - change from baseline in morning LH at Week 6. Modeling change from baseline by treatment group.

Morning LH at Baseline

Morning LH at Week 2

Morning LH Change from Baseline at Week 2

Morning LH at Week 4

Morning LH Change from Baseline at Week 4

Morning LH at Week 6

Morning LH Change from Baseline at Week 6

Change in Leuteinizing Hormone (LH)

Pearson correlation between 9 am morning testosterone and serial testosterone Cavg at Week 6.

Pearson correlation between 9 am morning testosterone and serial testosterone Cmin at Week 6.

Pearson correlation between 9 am morning testosterone and serial testosterone Cmax at Week 6.

9 AM morning testosterone correlated with Week 6 serial testosterone Cavg, Cmin, and Cmax.

If a subject did not have a Week 6 serial testosterone Cavg, Cmin, or Cmax then they were not included for that particular correlation calculation.

Androxal 6.25, 12.5, and 25 mg subjects combined into a single group.

Androxal Pooled Dose Levels

All Androxal subjects with Week 6 serial testosterone measurements.

Morning Testosterone Correlated With Serial Testosterone.

Androxal 6.25 mg/day

Androxal (enclomiphene citrate): capsule oral

1X a day 6 weeks

Androxal 12.5 mg/day

Androxal (enclomiphene citrate): capsule oral

1X a day 6 weeks

Androxal 25 mg/day

Androxal (enclomiphene citrate): capsule oral

1X a day 6 weeks

Enclomiphene Pharmacokinetic Parameters at Week 6 - Cmax.

ANOVA results - change from baseline in morning FSH at Week 2. Modeling change from baseline by treatment group.

ANOVA results - change from baseline in morning FSH at Week 4. Modeling change from baseline by treatment group.

ANOVA results - change from baseline in morning FSH at Week 6. Modeling change from baseline by treatment group.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone)	NCT01386606	Secondary Hypog...	Androxal (enclo... Testosterone	18 Years - 65 Years	Repros Therapeutics Inc.
The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone)	NCT01386606	Secondary Hypog...	Androxal (enclo... Testosterone	18 Years - 65 Years	Repros Therapeutics Inc.

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